Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

Gastrointestinal Diseases Clinical Trial

Official title:

Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572593
• Other study ID #: 16-008401
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: September 15, 2021

Study information

• Verified date: October 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers are trying to learn more about how individuals break down and process specific medications based on their genes. Pharmacogenomics (PGx) is a new, specialized field within individualized medicine. PGx is the study of how genes may affect the body's response to, and interaction with, some prescription medications. Genes carry information that determines things such as eye color and blood type. Genes can also influence how individuals process and respond to medications. Depending on genetic make-up, some medications may work faster or slower or produce fewer side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• Rome IV criteria for functional nausea and vomiting disorders (chronic nausea vomiting syndrome, cyclic vomiting syndrome), abdominal bloating/distention, dyspepsia, irritable bowel syndrome, chronic abdominal pain, functional diarrhea, or chronic constipation.

• On 1 or more medications identified in Appendix 1 on a daily basis for at least six months.

• Symptoms of moderate or severe severity on either of these 2 instruments: For IBS-SSS, use moderate (175-300) or severe (> 300) IBS. For FD - Score = 3 for any symptom on Nepean Dyspepsia Index.

• No prior pharmacogenomics assessment.

• Willingness to adjust medications based upon results of PGX testing.

• Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.

• Patients must have the ability to complete questionnaires by themselves or with assistance.

Exclusion Criteria:

• Patients who decline to be evaluated by a mental health professional during their evaluation.

• Rumination syndrome, cannabinoid hyperemesis syndrome, patients with a significant GI disease process (e.g., intestinal pseudo-obstruction, severe gastroparesis, megacolon) which, in the opinion of the investigator, is likely irreversible.

• Patients who, in the opinion of the investigator, are likely to undergo another major therapeutic intervention during the next 6 months (e.g., surgery or pelvic floor retraining by biofeedback therapy). However, other changes (e.g., medications) will not preclude participation in the study.

• Patients with any of the following per history, and review of medical record prior to study entry: any psychotic disorders, bipolar disorders, or major cognitive disorders; any active substance use disorders, other than tobacco; currently active suicidal ideation; current treatment with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS); discharge from a psychiatric inpatient hospital or intensive psychiatric outpatient program within 6 weeks prior to GI consultation.

• Patients who are unwilling or cannot, for any reason, adjust their medications.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Genetic:
• Pharmacogenomics (PGx) genetic testing
A buccal swab to collect cells from the inside the cheek

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects to have clinical management changes based on PGx results	Number of subjects that pharmacogenomic (PGx) results guided the clinical management of gastrointestinal disorders	3 months
Primary	Change in Irritable Bowel Syndrome (IBS) severity	Measured using the self-reported IBS severity scoring system (IBS-SSS) Questionnaire; 500 point continuous scale: 0= no symptoms to 500=maximum severity	Baseline, 3 months. 6 months
Primary	Change in Irritable Bowel Syndrome Quality of Life	Measured using the self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) survey; score ranges from 0 (poor QOL) to 100 (maximum QOL)	Baseline, 3 months. 6 months
Primary	Change in symptom severity with dyspepsia	Measured using the self-reported Nepean Dyspepsia Index (NDI) questionnaire which consists of a symptom checklist that measures frequency (0-4), intensity (0-5) and bothersomeness (0-4) of 15 upper gastrointestinal symptoms. The average score for each symptom is derived by averaging scores for frequency, intensity, and bothersomeness. Scores of 3 respectively represent a frequency of 9 to 12 days/week, moderate intensity, and a bothersomeness of "quite a bit".	Baseline, 3 months. 6 months
Secondary	Change in anxiety	Measured using the self-reported Generalized Anxiety Disorder-7 (GAD-7) questionnaire; score range 0-21 points, higher scores indicate worse symptoms	Baseline, 3 months, 6 months
Secondary	Change in Patient Health Questionnaire Score	Measured using the self-reported Patient Health Questionnaire (PHQ-9); score range 0-27 points, higher scores indicate worse symptoms	Baseline, 3 months, 6 months
Secondary	Change in general well-being	Measured using the self-reported Global Wellbeing Likert scale; subjects asked to rate their general health perception on a scale range of 1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor	Baseline, 3 months, 6 months
Secondary	Change in Pain score	Measured using the self-reported McGill Pain score; score range 0-78; higher scores indicate worse pain	Baseline, 3 months, 6 months

External Links

•   Mayo Clinic Clinical Trials